A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Alcohol Liver Disease

December 3, 2025 updated by: Zhujiang Hospital
alcohol-associated liver disease (ALD) is a leading cause of cirrhosis, yet the role of gut microbiota-derived peptidoglycan (PG) metabolites in liver injury remains unclear. This study aimed to elucidate the role of microbial DL-endopeptidases, which generate NOD2 ligands, in modulating alcohol-induced liver injury.Participants will provide stool samples.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Zhujiang Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Meet eligibility criteria

Description

Inclusion Criteria:

(1) patients diagnosed with liver cirrhosis based on clinical-pathologic features including liver history and endoscopic or radiologic findings (the presence of clinical cirrhosis was adjudicated in a blinded fashion by two separate hepatology experts; to be included, both experts were required to agree on the presence of clinical cirrhosis) and (2) all patients with chronic liver disease were required to have evidence of clinical liver disease for at least 6 months and were required to have an identifiable etiology of liver disease, including alcohol-related liver diseases (based on a history of alcohol use disorder or a past history of alcohol consumption of greater than 2 ounces of ethanol per day for men or 1 ounce of ethanol per day for women (for greater than 10 years) with no other cause of liver disease identified), NAFLDs, viral hepatitis B or C (detected by HCV RNA or HBV DNA measurement) or autoimmune liver disease (based on international autoimmune scoring criteria).

Exclusion Criteria:

(1) individuals treated with antibiotics, probiotics or proton pump inhibitors within 1 month before sample collection; (2) any participant undergoing a gastrointestinal surgical procedure or colonoscopy within 6 months before sample collection; (3) any individual with uncontrolled infection; and (4) individuals with uncontrolled systolic blood pressure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ALD-related cirrhosis
This cohort consists of patients with alcohol-related liver cirrhosis, diagnosed based on clinical-pathological assessment with confirmation by two hepatologists. All patients had chronic liver disease for ≥6 months with an established etiology (primarily alcohol-related, defined as >2 oz/day ethanol for men or >1 oz/day for women for >10 years). Key exclusions include recent (within 1 month) use of antibiotics/probiotics/PPIs, recent (within 6 months) gastrointestinal procedures, and presence of uncontrolled infection or hypertension.
Other: An observational, non-interventional study design.
An observational, non-interventional study design.
health
This cohort consists of age- and sex-matched healthy controls recruited from a Health Checkup Center, with no clinically diagnosed chronic diseases.
Other: An observational, non-interventional study design.
An observational, non-interventional study design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal NOD2-stimulating activity, measured using a HEK-Blue-hNOD2 reporter cell assay.
Time Frame: Baseline (pre-treatment)
To explore the potential of peptidoglycan fragments as screening or diagnostic biomarkers for alcohol-related liver disease.
Baseline (pre-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Study Director: Xiaolong He, xiaolong, Southern Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ZhujingGS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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